The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Lead Stylet,models 6505,6506,6507,6508.
| Device ID | K992863 |
| 510k Number | K992863 |
| Device Name: | LEAD STYLET,MODELS 6505,6506,6507,6508 |
| Classification | Stylet, Catheter |
| Applicant | GUIDANT CORP. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Contact | Sheryl Poganski |
| Correspondent | Sheryl Poganski GUIDANT CORP. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Product Code | DRB |
| CFR Regulation Number | 870.1380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-25 |
| Decision Date | 1999-11-12 |
| Summary: | summary |